ChARM

Target Regions

East Africa

Target SDGs

Market Suggested Retail Price

$99.00

Target Users (Target Impact Group)

Small and Medium-sized Enterprises

Distributors / Implementing Organizations

Maternova

Competitive Landscape

Direct competitors include neoGuard Vital Signs Monitor for Newborns and Raybaby Monitor.

Manufacturing/Building Method

This product is manufactured by Philips India Limited.

Intellectural Property Type

Select Type

User Provision Model

End user can procure a ChARM by ordering on Maternova website.

Distributions to Date Status

Unknown, but it is estimated that 330M neonates and young children annually can be helped with the ChARM.

Design Specifications

In the box, the user will receive: one device (Community HW/Professional HW depending on the model purchased), one instruction for use (IFU), one Quick reference guide (QRG), one belt, and a power adapter with plug heads and cable in case of PHW. The ChARM comprises an accelerometer based device, with a belt to attach the device to the child. If the child's breathing rate is under the limit based on the World Health Organization’s IMCI (Integrated Management of Childhood Illness) guidelines, the device will light up green, meaning the child does not have fast breathing. If the breathing rate is above the limit, the device will light up red and blink, indicating that the child has fast breathing. There are two variants, Community health worker model called CHW and a Professional Health worker model called PHW. Specifications: - Principle: Uses a 3D accelerometer with advanced signal processing to measure the specific abdominal motions related to breathing. - Accuracy: ±2 Breaths per minute when measured under the recommended conditions. - Measurement Range: 10 to 150 Breaths per minute. - Mode of Operation: Non-Continuous. - Power Specifications for Charging Adapter PHW: Input Voltage: 100-240V@50/60 Hz; Output Voltage: 5VDC Output; Current: > 0.5A. - Battery Type: Alkaline for Community Healthcare Worker (CHW) and Rechargeable NiMH for PHW. - Automatic Shut-off: After approximately two minutes of inactivity. - Memory: 300 measurement records PHW. - Operating Conditions: 0 °C to 40 °C; 10% to 90% RH. - Dimensions (approx.): 65 x 65 x 28 mm (without belt). - Weight (approx.): 95 g including belt Breathing Rate Guidelines: - <2 months: ?60 breaths/min - 2-11 months: ?50 breaths/min - 12-59 months: ?40 breaths/min

Product Schematics

Technical Support

Distributor can be contacted for technical support. Users may also refer to the instructions for use.

Replacement Components

Yes, the user should contact the distributor where he or she procured the device.

Lifecycle

2,000 measurements over two-year usage for the CHW model, 4,380 measurements over three years of usage, and 200 measurements per full charge cycle for PHW model. The PHW model uses a rechargeable battery that can run for several days with normal use (~10 measurements/day).

Manufacturer Specified Performance Parameters

Easy to use, easy monitoring and adherence to the WHO IMCI guidelines, making it easier to classify, diagnose and to reduce unnecessary referrals.

Vetted Performance Status

Results: - Root Mean Squared Error( RMSE) values (overall: 1.9 and balanced: 2.1) were close to 2 - Balanced percentage below 2 RPM as 83% which is higher than values revealed by clinician (73%) These study results indicate that ChARM device is at least as good as a trained physician for measuring breath count. Given these findings, ChARM device can be recommended an acceptably accurate and alternate method of breath count for under 5 children population.

Safety

This device must be used only by trained and authorized personnel and is designed for use on full-term babies (37+ weeks gestation) without any chest or belly-supportive devices. The system should be attached to clothing, or if on skin, only intact skin. Always use the provided belt, ensuring it’s not too tight to avoid injuries. Never connect the charging cable while the device is on a child, and charge it fully before the first use. Keep the device clean, disinfecting with 70% isopropyl alcohol after each use, and avoid sterilizing it. Dispose of the device responsibly according to local regulations once it reaches the end of its lifespan.

Complementary Technical Systems

Pulse oximeter, pulse sensor, thermometer

Academic Research and References

Compliance with regulations

CE-Mark approved ChARM gives qualitative feedback to the healthcare provider based on the World Health Organization’s IMCI (Integrated Management of Childhood Illness) guidelines to diagnose fast breathing rates.